Manufacturing Operator
About The Position
The Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production. This role reports to the Production Supervisor and is responsible for ensuring compliance with all applicable policies and procedures, including those regulated by PPS and various regulatory agencies. The operator will also be involved in line clearances, cleaning and sanitization of equipment, operation of aseptic filling and vial washing equipment, filter testing, and weighing/measuring raw materials. Additionally, the role includes executing validation protocols, maintaining records, and ensuring a clean environment in compliance with regulatory requirements. The Manufacturing Operator must read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures, provide feedback on potential process improvements, and participate in troubleshooting activities. Reviewing completed production documentation for quality and cGMP compliance, initiating action for process deviations, and performing on-the-job training for new operators are also key responsibilities. The role also involves routine housekeeping, maintaining cleanliness and routine maintenance of the work area and equipment, and collaborating effectively with other functional groups to achieve production goals.
Requirements
- High School education or equivalent
- 2+ years’ working within an industrial or manufacturing environment
- Mechanical aptitude, ability to operate processing equipment
- Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)
- Ability to read, interpret, and follow written instructions
- Team player committed to quality and working effectively with others
- Track record of consistent attendance and overall reliability
Nice To Haves
- Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred
Responsibilities
- Consistently comply with all applicable policies and procedures, including those regulated by PPS and various regulatory agencies
- Performs line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment
- Operate and maintain production related equipment
- Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities
- Execute validation protocols for processes and equipment
- Maintain records and a clean environment to comply with regulatory requirements
- Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
- Review current SOPs and provide feedback on potential process improvements
- Participate in troubleshooting and process improvement activities including corresponding documentation activities
- Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance
- Initiate appropriate action when process deviations occur
- Perform on-the-job training for new and developing operators
- Routinely perform housekeeping assignments, maintain cleanliness and routine maintenance of the work area and equipment
- Collaborate effectively and communicate with other functional groups, including: quality, validation, supply chain to ensure production goals are achieved
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
